Contract Pharma Staff05.20.20
Rapid Micro Biosystems, Inc., a provider of fully automated, high-throughput, rapid microbial detection technology for biopharmaceutical manufacturing, has completed a $120 million financing, including an equity investment led by Ally Bridge Group, along with Endeavour Vision and existing investors including Bain Capital Life Sciences, Longitude Capital, Xeraya Capital and Asahi Kasei Medical.
With the increasing number and complexity of drug products, manufacturing processes are more susceptible to the impact of microbial contamination, such as bacteria, mold and fungi. These events can lead to variability of the drug product and lengthy investigations requiring shutdown of operations and product recalls and potentially leading to drug shortages.
There were nearly five times more recalls of drug products and raw materials due to microbial contamination during 2012-2019 than in the previous seven year period, along with a three-fold increase in the diversity of microbes identified as contaminants.1 With current trends, Rapid Micro Biosystems has seen growing adoption of its fully-automated microbial detection platform, Growth Direct.
A majority of the top 20 industry players have already adopted Growth Direct, and the company has seen accelerating global demand for its system as regulators push for more stringent quality and traceability, and as volumes of high-value drug production increase.
The Growth Direct platform automates the majority of standard microbial QC tests, replacing the time- and labor-intensive manual QC processes and delivering results in half the time. Fully automated microbial contaminant testing can be performed with minimal human handling and remote system monitoring and data reporting capabilities to ensure manufacturing continuity at a time when QC labs must remain fully operational, despite reduced staff due to COVID-19 restrictions.
The ability to compress timelines and ensure sterility is particularly suited to bioprocessing for state-of the-art manufacturing and for complex new therapeutic modalities, as well as ensuring the delivery of safe medicines for patients.
Driving Commercial Expansion
This new round of financing will support the next stage of commercial growth for Rapid Micro Biosystems and includes senior debt financing from Kennedy Lewis Investment Management, in addition to equity capital. The proceeds will fund further commercial expansion in the United States, Europe and Asia, and support investments in global supply chain and manufacturing capability.
In addition, the financing will accelerate new product development, including a rapid sterility test for the final release of products which can significantly shorten the supply chain by accelerating deployment of biologics, vaccines and cell therapies to patients. Development of the rapid sterility test has been advanced through a partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA) for responsiveness to pandemic threats.
“With this financing, Rapid Micro Biosystems will cement its role as a key player in the global pharmaceutical supply chain, deploying the Growth Direct platform across the globe in facilities making products used by millions of patients every year,” commented David Hirsch, managing director of Longitude Capital.
Reference:
1 Jimenez, L., Analysis of FDA Enforcement Reports (2012-2019) to Determine the Microbial Diversity of Contaminated Non-Sterile and Sterile Drugs, American Pharmaceutical Review, October 24, 2019.
With the increasing number and complexity of drug products, manufacturing processes are more susceptible to the impact of microbial contamination, such as bacteria, mold and fungi. These events can lead to variability of the drug product and lengthy investigations requiring shutdown of operations and product recalls and potentially leading to drug shortages.
There were nearly five times more recalls of drug products and raw materials due to microbial contamination during 2012-2019 than in the previous seven year period, along with a three-fold increase in the diversity of microbes identified as contaminants.1 With current trends, Rapid Micro Biosystems has seen growing adoption of its fully-automated microbial detection platform, Growth Direct.
A majority of the top 20 industry players have already adopted Growth Direct, and the company has seen accelerating global demand for its system as regulators push for more stringent quality and traceability, and as volumes of high-value drug production increase.
The Growth Direct platform automates the majority of standard microbial QC tests, replacing the time- and labor-intensive manual QC processes and delivering results in half the time. Fully automated microbial contaminant testing can be performed with minimal human handling and remote system monitoring and data reporting capabilities to ensure manufacturing continuity at a time when QC labs must remain fully operational, despite reduced staff due to COVID-19 restrictions.
The ability to compress timelines and ensure sterility is particularly suited to bioprocessing for state-of the-art manufacturing and for complex new therapeutic modalities, as well as ensuring the delivery of safe medicines for patients.
Driving Commercial Expansion
This new round of financing will support the next stage of commercial growth for Rapid Micro Biosystems and includes senior debt financing from Kennedy Lewis Investment Management, in addition to equity capital. The proceeds will fund further commercial expansion in the United States, Europe and Asia, and support investments in global supply chain and manufacturing capability.
In addition, the financing will accelerate new product development, including a rapid sterility test for the final release of products which can significantly shorten the supply chain by accelerating deployment of biologics, vaccines and cell therapies to patients. Development of the rapid sterility test has been advanced through a partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA) for responsiveness to pandemic threats.
“With this financing, Rapid Micro Biosystems will cement its role as a key player in the global pharmaceutical supply chain, deploying the Growth Direct platform across the globe in facilities making products used by millions of patients every year,” commented David Hirsch, managing director of Longitude Capital.
Reference:
1 Jimenez, L., Analysis of FDA Enforcement Reports (2012-2019) to Determine the Microbial Diversity of Contaminated Non-Sterile and Sterile Drugs, American Pharmaceutical Review, October 24, 2019.
